Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Monday, July 16, 2007

Avandia to be Reviewed by FDA Board with Conflicted Members

We have posted quite a bit, most recently here, about the spinning that went on after the New England Journal of Medicine published a meta-analysis which suggested that the anti-diabetic drug rosiglitazone (Avandia, by GlaxoSmithKline) might have heretofore unrecognized cardiovascular adverse effects. Later this month, the US Food and Drug Administration (FDA) will convene an advisory panel to discuss the risks of Avandia and similar drugs. Bloomberg just reported,

Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.

The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have.

Bloomberg was able to find out something about some of the conflicted panel members.

The FDA's documents for Thomas Pickering, a professor at Columbia University Medical Center in New York, said he was paid less than $10,001 a year for serving on a drugmaker's advisory board and had stocks in drug companies. Pickering, 67, who is a voting member of the panel, said in an interview that he served earlier this year on an advisory board to Bristol-Myers Squibb Co., a New York-based drugmaker....

Another voting member, David S. Schade, a professor at the University of New Mexico School of Medicine in Albuquerque, received less than $10,001 a year as a member of a speaker's bureau for a drugmaker whose products compete with those to be discussed at the panel meeting, according to the FDA.

[John R.] Teerlink, director of the heart-failure clinic at the San Francisco Veterans Affairs Medical Center, also received $10,001 to $50,000 a year as a study reviewer for a drugmaker, which he identified as Bristol-Myers. The FDA paperwork doesn't make clear whether Teerlink will vote.

Steven Nissen, first author of the controversial meta-analysis, and Curt D. Furberg, who wrote an accompanying editorial, will both serve as non-voting panel members.

Of course, the conflicted panel members say that their conflicts will not affect how they will vote.

The financial ties won't affect his recommendations, Pickering said.

'I would not serve on the panel if I felt that I had conflicts that would interfere with my ability to objectively interpret the data and make decisions to help protect the public health,' Teerlink, 46, said in an interview.

Others differ.

'They shouldn't appoint people with conflicts of interest,' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. 'The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.'

If you accept the idea that even the gift of a pen might affect a physician's therapeutic judgment, why wouldn't a consulting job paying thousands a year affect an advisory panel member's scientific judgment? After all, if one is paid thousands to consult for company x, wouldn't one tend to favor company x's products and services?

We noted here that the Avandia spin cycle was receiving much of its rotational velocity from people who had a variety of relevant vested interests. It would have been nice if we had confidence that the FDA review of the drug's possible adverse effects would be done by people with no relevant vested interests. But that, it appears, won't be the case.

We fear that practicing physicians and other health professionals in the trenches, and the public at large, will just get more and more disillusioned about health care as long as the discourse is dominated by people with vested interests (other than in advancing health, education, and science.)

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